FDA 510(k) Application Details - K002503

Device Classification Name System, Monitoring, Perinatal

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510(K) Number K002503
Device Name System, Monitoring, Perinatal
Applicant ANALOGIC CORP.
8 CENTENNIAL DR.
PEABODY, MA 01960 US
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Contact STEVEN A CLARKE
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Regulation Number 884.2740

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Classification Product Code HGM
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Date Received 08/14/2000
Decision Date 11/09/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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